Stents, Drains And Dilators For The Biliary Ducts
FDA product code FGE · 462 cleared devices
Class 2
Gastroenterology, Urology
- Regulation
- 21 CFR 876.5010
- Review panel
- GU
- Implant
- Yes
- Life sustaining
- Yes
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1982-08-10 – 2026-09-18
FGE
2003-03-21
FGE
2003-03-10
SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM
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FGE
2003-03-10
LIFESTENT BILIARY ENDOPROSTHESIS
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FGE
2003-02-11
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
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FGE
2003-01-21
EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830
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FGE
2003-01-06
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
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FGE
2003-01-02
BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM
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FGE
2002-12-20
FLEXIMA BILIARY CATHETER
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FGE
2002-12-19
VIABIL BILIARY ENDOPROSTHESIS
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FGE
2002-12-13
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
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FGE
2002-10-25
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
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FGE
2002-10-25
BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
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FGE
2002-08-14
SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
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FGE
2002-07-19
MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS)
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FGE
2002-07-02
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010
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FGE
2002-06-28
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
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FGE
2002-06-21
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
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FGE
2002-05-08
WILSON-COOK ZILVER BILIARY STENT
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FGE
2002-04-16
INTRASTENT LD (LARGE DIAMETER) STENT
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FGE
2002-04-12
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
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FGE
2002-04-02
BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM
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FGE
2002-03-01
MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON
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FGE
2002-02-11
SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
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FGE
2002-01-18
MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
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FGE
2002-01-18
BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)
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FGE
2002-01-17
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
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FGE
2002-01-14
MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE)
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FGE
2002-01-07
DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM
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FGE
2001-11-28
ULTRA-THIN SDS BALLOON DILATATION CATHETER
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FGE
2001-11-16
FANELLI BILIARY STENT
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FGE
2001-11-15
WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
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FGE
2001-10-24
MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX
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FGE
2001-10-11
BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM
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FGE
2001-10-05
MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
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FGE
2001-09-07
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
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FGE
2001-09-07
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
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FGE
2001-08-27
PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
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FGE
2001-08-23
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
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FGE
2001-08-22
BRIDGE FX
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FGE
2001-08-17
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
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FGE
2001-08-13
INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
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FGE
2001-08-13
COOK ZILVER BILIARY STENT
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FGE
2001-08-01
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
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FGE
2001-08-01
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
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FGE
2001-08-01
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
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FGE
2001-08-01
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
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FGE
2001-07-31
R STENT BILIARY ENDOPROSTHESIS
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FGE
2001-07-18
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
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FGE
2001-06-15
OMNILINK .035 BILIARY STENT SYSTEM
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FGE
2001-05-08
OMNILINK .018 BILIARY STENT SYSTEM
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FGE
2001-04-12
RX HERCULINK PLUS BILIARY STENT SYSTEM
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FGE
2001-03-22
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
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FGE
2001-03-16
PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM
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FGE
2001-02-16
VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726
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FGE
2001-01-24
INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
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FGE
2001-01-23
HORIZONS ERCP CANNULA
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FGE
2001-01-09
BARD MEMOTHERM ENDOSCOPIC BILIARY STENT
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FGE
2001-01-05
BARD LUMINEXX BILIARY STENT
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FGE
2001-01-04
GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE
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FGE
2000-12-28
INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
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FGE
2000-12-07
INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS
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FGE
2000-11-22
S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)
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FGE
2000-11-22
MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
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FGE
2000-10-30
NIR BILIARY STENT
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FGE
2000-10-12
DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM
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FGE
2000-10-12
NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER
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FGE
2000-08-30
MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
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FGE
2000-08-28
INTRASTENT DOUBLESTRUT PARAMOUNT
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FGE
2000-07-31
ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER
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FGE
2000-07-18
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
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FGE
2000-06-27
BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM
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FGE
2000-06-05
MEDTRONIC AVE BRIDGE X3 STENT
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FGE
2000-05-19
WALLSTENT BILIARY ENDOPROSTHESIS
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FGE
2000-05-17
RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100
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FGE
2000-05-17
OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1
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FGE
2000-04-14
INTRASTENT DOUBLESTRUT XS STENT
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FGE
2000-04-12
1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
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FGE
2000-03-23
SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER
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FGE
2000-03-23
CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY
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FGE
2000-03-17
OTW MEGALINK SDS BILIARY STENT SYSTEM
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FGE
2000-02-01
INTRASTENT DOUBLESTRUT LD
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FGE
2000-01-07
MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B
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FGE
2000-01-06
DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45
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FGE
2000-01-06
BARD MEMOTHERM FLEXX BILIARY STENT
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FGE
1999-12-30
WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
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FGE
1999-12-23
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
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FGE
1999-11-28
S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
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FGE
1999-11-26
PBN DILATORS
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FGE
1999-11-17
MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,
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FGE
1999-10-29
PALMAZ XL TANSHEPATIC BILIARY STENTS
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FGE
1999-10-21
MEDTRONIC AVE BRIDGE STENT
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FGE
1999-10-15
MODIFICATION TO INTRASTENT
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FGE
1999-10-08
RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM
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FGE
1999-09-15
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, CORDIS CRIMPING TOOLS, CORDIS INTRODUCER TUBE
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FGE
1999-09-02
RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18
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FGE
1999-09-01
INTRASTENT II
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FGE
1999-08-31
MEDTRONIC AVE BRIDGE STENT
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FGE
1999-08-12
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS
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FGE
1999-08-04
INTRASTENT
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FGE
1999-08-04
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES
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